West Penn Allegheny Physicians Help Pioneer Innovative Blood Test That Improves Lupus Diagnosis

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West Penn Allegheny Health System physicians were instrumental in the development and trials of a new diagnostic test that pinpoints proteins which are useful in ruling-in lupus and ruling-out similar Disorders. The Avise-SLE blood is now commerically available nationwide.

By ensuring proper, quick diagnosis, we can get patients the best treatment options before major complications, such as organ damage, occur.

A new blood test designed by physicians and scientists from the West Penn Allegheny Health System to help clinicians diagnose lupus with greater ease and accuracy is now commercially available across the United States.

The Avise-SLE test uses one blood sample from a patient to check for five distinct bio-markers that help to rule-in the diagnosis of systemic lupus erythematosus while ruling out other rheumatic diseases.

“Lupus has been notoriously difficult to diagnose and frequently misdiagnosed because there was never a specific blood test to administer to patients with suspected lupus,” said Joseph Ahearn, MD, Chief Scientific Officer and Vice President of West Penn Allegheny Health System’s (WPAHS) Allegheny Singer Research Institute. “The availability of this test will significantly improve physicians’ ability to reach a definitive diagnosis.”

Dr. Ahearn and Susan Manzi, MD, MPH, co-founders of the Lupus Center of Excellence at WPAHS, began working to develop the test more than a decade ago at the University of Pittsburgh with colleagues Amy Kao, MD, MPH, and Chau-Ching Liu, MD, PhD, who subsequently joined WPAHS. The group initiated their work in conjunction with the National Institutes of Health’s Biomarker Definition Working Group.

A validation study of Avise-SLE was completed last year at WPAHS and a multi-center trial of the panel was conducted at select hospitals across the nation, Dr. Ahearn said.

The test uses flow cytometry to measure the levels of various proteins or cell-bound complement activation products (CB-CAPs) deposited on the surfaces of all blood cells. Evaluating a combination of CB-CAPs provides results that are more sensitive and specific to lupus diagnosis than the previous gold-standard lupus tests, serum C3 and C4 and anti-dsDNA.

In both the multi-center study and a subsequent validation study, Avise-SLE was able to confirm a lupus diagnosis with 78 percent accuracy and rule out other rheumatic diseases with 86 percent accuracy. Ruling out a number of diseases that mimic lupus is a crucial part of obtaining the correct diagnosis and assigning the correct treatment, Dr. Manzi said.

“Serious complications of lupus can be prevented or delayed if patients receive early intervention,” said Dr. Manzi. “By ensuring proper, quick diagnosis, we can get patients the best treatment options before major complications, such as organ damage, occur.”

Lupus is a chronic autoimmune disease that causes inflammation and damage to parts of the body, including skin, joints and kidneys. More than 1.5 million Americans have some form of the disease, according to the Lupus Foundation of America.

Avise- SLE is available through Exagen Diagnostics, Inc., a molecular diagnostics laboratory that discovers, develops and markets tests for rheumatolgoists and gastroenterologists.


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Jennifer Davis
Allegheny General Hospital
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